In order to implement the "Opinions of the General Office of the State Council on Fully Deepening the Reform of Drug and Medical Device Supervision and Promoting the High quality Development of the Pharmaceutical Industry" (Guobanfa [2024] No. 53), improve the quality of generic drug application materials, and promote the improvement of generic drug quality, the Drug Evaluation Center has organized the drafting of the "Requirements for Writing Pharmaceutical Materials in the Second Module of Chemical Drug Generic Drug Market License Application (Raw Material) (Trial)" and the "Requirements for Writing Pharmaceutical Materials in the Second Module of Chemical Drug Generic Drug Market License Application (Preparation) (Trial)" (hereinafter referred to as the writing requirements, see attachments 1 and 2) based on the practice of drug evaluation. After being reviewed and approved by the National Medical Products Administration, the following implementation requirements are hereby released:

1、 The scope of application for this writing requirement is the application for marketing authorization of generic drugs for chemical drugs (including Class 3, Class 4, Class 5.2 of chemical drugs and active pharmaceutical ingredients).

2、 This writing requires implementation from March 1, 2026. Prior to the implementation date, applicants for generic drugs are encouraged to submit application materials in accordance with this writing requirement from the date of publication of this notice.

The applicant shall submit the Word version of Module 2 Pharmaceutical Materials through the "Pharmaceutical Review Materials" section of the "Applicant Window" within 10 days after the acceptance of the declared variety, and also submit a statement of consistency between the Word and PDF versions of the declared materials.

This is to inform you.

Attachment:
1. Requirements for Writing Pharmaceutical Information in Module 2 of the Application for Marketing Authorization of Generic Drugs for Chemical Drugs (Active Pharmaceutical Ingredients) (Trial)
2. Requirements for Writing Pharmaceutical Information in Module 2 of the Application for Marketing Authorization of Generic Drugs for Chemical Drugs (Preparation) (Trial)

National Medical Products Administration Drug Review Center
August 28, 2025